Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Part of paid clinical trials in Torrance, California.

Sponsor
Retina Macula Institute
Study ID
NCT01571232
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dexamethasone intravitreal implant — DRUG
    Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
  • intravitreal bevacizumab — DRUG
    Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Study Details

The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

Key Dates

First listed
Apr 5, 2012
Start date
Apr 30, 2012
Status verified
Mar 2021
Primary completion
Feb 28, 2014
Completion
Mar 31, 2015

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ozurdex
    Patients in this group receive Ozurdex at initial visit and at month 4
  • Active Comparator: Avastin
    Patients in this group receive Avastin Q1 month for 5 months.

Primary Outcome Measure

The Change in Visual Acuity (Number of ETDRS Letters). [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Macula InstituteTorranceCalifornia90503-

Find similar trials in Torrance, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Macula Institute· Torrance, CA

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